Antiflatulent

Manufacturer: Major Pharmaceuticals | Guardian Drug Company
Effective date: 2025-12-03
Label type: Human OTC Drug Label
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:19:32

Label at a glance#

ProductAntiflatulent

Active ingredientDIMETHICONE

Label structure10 sections

Dosage and administration

chew 2 to 4 tablets thoroughly as needed after meals and at bedtime do not exceed 6 tablets per day unless directed by a physician

Storage and handling

do not use if inner seal is broken store at room temperature avoid high humidity and excessive heat, above 40 o C (104 o F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

PURPOSE

OTC - PURPOSE SECTION

Antigas

USE(S)

INDICATIONS & USAGE SECTION

relieves:

pressure
bloating
symptoms referred to as gas

WARNINGS

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
do not exceed 6 tablets per day unless directed by a physician

OTHER INFORMATION

STORAGE AND HANDLING SECTION

do not use if inner seal is broken
store at room temperature
avoid high humidity and excessive heat, above 40^oC (104^oF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

QUESTIONS

OTC - QUESTIONS SECTION

Call (800) 616-2471

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0904-7206-60
MAJOR

Simethicone

Simethicone 80 mg

antiflatulent

relieves:

gas pain
pressure
bloating

100 Chewable Tablets

3-103-100-maj-o.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
314216	simethicone 80 MG Chewable Tablet	PSN	5
314216	simethicone 80 MG Chewable Tablet	SCD	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0309047206605	GTIN-13: 0309047206605 EAN-13: 0309047206605 GTIN-12: 309047206605 UPC-A: 309047206605 GTIN storage (14 digits): 00309047206605	3-103-100-maj-o.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-7206-60	Antiflatulent	100 in 1 BOTTLE	TABLET, CHEWABLE	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7206-60	EA - Each	0904-7206	14cb7359-be3a-4185-8c75-a9153618462b	1	2022-04-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

Antiflatulent
Simethicone
DIMETHICONE
SUGARCANE
MALTODEXTRIN
DEXTROSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0904-7206	0904-7206-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
SUGARCANE	81H2R5AOH3	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antiflatulent	SIMETHICONE	Major Pharmaceuticals	d321114e-09ac-4252-a6e6-3dbc3a451ee6	2025-12-03	Warnings	Exact identifier ndc (package): 0904-7206-60 ndc (product): 0904-7206 ndc11 (package): 00904720660 spl id: 449e7aee-627d-4f29-b671-1787d287ca4f spl set id: d321114e-09ac-4252-a6e6-3dbc3a451ee6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.